What's Happening?
Hemostemix, a company specializing in autologous stem cell therapy, presented data on its ACP-01 treatment at the University of Florida Grand Rounds. The session, led by neurosurgeon Dr. Fraser Henderson
and Hemostemix CEO Thomas Smeenk, highlighted the safety and functional gains of ACP-01, which is derived from patient blood and has shown promising results in treating ischemic and dilated non-ischemic cardiomyopathy. The therapy demonstrated improvements in cardiac function and reduced amputation and death rates in chronic limb-threatening ischemia patients. Under Florida SB 1768, effective July 2025, physicians can offer autologous stem-cell therapies for pain, with ACP-01 now available outside of trials in Florida.
Why It's Important?
The presentation underscores the potential of ACP-01 as a significant advancement in regenerative medicine, offering a new treatment option for patients with severe cardiovascular conditions. The therapy's ability to improve cardiac function and reduce mortality rates could have substantial implications for healthcare costs and patient outcomes, particularly in economically disadvantaged populations. The availability of ACP-01 in Florida represents a shift towards more accessible and innovative treatments, potentially setting a precedent for other states to follow.
What's Next?
Hemostemix plans to continue expanding the availability of ACP-01, with treatments scheduled in Florida and The Bahamas. The company is also circulating program briefs to clinicians for site onboarding, aiming to generate high-quality real-world evidence to complement ongoing studies. The establishment of a 501(c)(3) organization will help economically disadvantaged patients access treatment, further broadening the therapy's reach.
Beyond the Headlines
The introduction of ACP-01 in Florida could stimulate discussions on the ethical and regulatory aspects of stem cell therapies, particularly concerning informed consent and manufacturing standards. As the therapy gains traction, it may influence public policy and healthcare practices, encouraging more states to adopt similar measures.
